Anacor Pharmaceuticals Announces Positive Top-Line Results From Two Phase 3 Pivotal Studies of Crisaborole Topical Ointment, 2% in Patients With Mild-to-Moderate Atopic Dermatitis

  • Crisaborole, a novel non-steroidal topical anti-inflammatory PDE-4 inhibitor, achieved statistically significant results on all primary and secondary endpoints in both studies and demonstrated a safety profile consistent with previous studies

  • Anacor expects to submit a New Drug Application for crisaborole to the U.S. Food and Drug Administration in the first half of 2016

Anacor to Host a Conference Call Today at 7:30 a.m. ET / 4:30 a.m. PT to Discuss Results

PALO ALTO, Calif.-- Anacor Pharmaceuticals, Inc. (ANAC) today announced preliminary top-line results from its two Phase 3 pivotal studies of Crisaborole Topical Ointment, 2% (formerly AN2728), a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. In both studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies.

Published: 13 July 2015
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EyeGate Signs Licensing Agreement with Valeant Pharmaceuticals for EGP-437 Combination Product in Uveitis

Company to Receive Upfront Cash Payment, Milestones and Royalties on Sales of Product

WALTHAM, Mass., July 10, 2015 -- Eyegate Pharmaceuticals, Inc. (EYEG) ("EyeGate" or the "Company"), a specialty pharmaceutical company that focuses on developing and commercializing therapeutics and drug delivery systems for treating diseases of the eye, today announced that it has entered into an exclusive, worldwide licensing agreement with a subsidiary of Valeant Pharmaceuticals International, Inc. (VRX) (VRX) ("Valeant") through which EyeGate has granted Valeant exclusive, worldwide commercial and manufacturing rights to its EyeGate(R) II Delivery System and EGP-437 combination product ("Product") in the field of uveitis, as well as a right of last negotiation to license the Product for other indications.

Published: 10 July 2015
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Dynavax Announces Third Independent DSMB Recommendation to Continue Phase 3 Study of HEPLISAV-B(TM) and Updates Financil Status

BERKELEY, CA--(Jul 9, 2015) - Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the independent Data and Safety Monitoring Board (DSMB) charged with periodically reviewing safety data from HBV-23, the ongoing Phase 3 clinical study of HEPLISAV-B, Dynavax's investigational adult hepatitis B vaccine, has completed its third prespecified review and has recommended that the study continue unchanged.

The third DSMB review included safety data for all enrolled subjects collected through the data cut-off in June. As of the cut-off, all continuing subjects who had received the second immunization (which was the last active dose for HEPLISAV-B subjects) had reached at least 8 months of the requisite one year follow-up after the second immunization. The DSMB reviewed unblinded tables and listings presenting key safety data. Based on this review, the DSMB recommended continuing HBV-23 with no change to the study.

Published: 09 July 2015
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Prima BioMed Receives Positive Scientific Advice From the European Medicines Agency for Its Lead Product, IMP321

The EMA Has Now Confirmed in Writing Its Endorsement of the Development Program of IMP321 in Metastatic Breast Cancer

SYDNEY, AUSTRALIA--(Jul 7, 2015) - Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) ("Prima" or the "Company"), a leading immuno-oncology company, is pleased to announce that it has received positive Scientific Advice from the European Medicines Agency ("EMA" or the "Agency") on the development path for its lead product, IMP321 in metastatic breast cancer.

The EMA, located in London, is the agency responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. After dialogue between Prima and the EMA, the Agency has now confirmed in writing its endorsement of the development program of IMP321 in metastatic breast cancer.

Published: 07 July 2015
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Oncolytics Biotech® Inc. Collaborators Present Final Data from REO 017 Clinical Study in Pancreatic Cancer

--Report More Than Doubling in One-Year Survival and Nearly Five-Fold Increase in Two-Year Survival as Compared to Historical Controls-- 

CALGARY, July 6, 2015  - Oncolytics Biotech® Inc. ("Oncolytics") (TSX:ONC.TO ) (NASDAQ:ONCY ) today announced that Dr. Devalingam Mahalingam of the Cancer Therapy and Research Centre, University of Texas Health Science Centre San Antonio, made a poster presentation at the ESMO World Congress on Gastrointestinal Cancer. The poster, titled "Oncolytic Virus Therapy in Pancreatic Cancer: Clinical Efficacy and Pharmacodynamic Analysis of REOLYSIN® in Combination with Gemcitabine in Patients with Advanced Pancreatic Adenocarcinoma," covers final results from the Company's REO 017 Phase 2 study.

Published: 06 July 2015
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